FDA.reportPublic FDA data

Adaptive Cylindrical Cuff, Limited Reuse

Primary DI
M995995000181
Brand
Adaptive Cylindrical Cuff, Limited Reuse
Company
Delfi Medical Innovations Inc
Model
9-9500-018
Device description
Delfi Adaptive Tourniquet Cuffs are available in a selection of lengths to facilitate a proper fit, and color coded for size identification. Each Delfi Adaptive Tourniquet Cuff includes a single use Matching Limb Protection Sleeve. Delfi Adaptive Tourniquet Cuffs are provided sterile, and may be reused in a non-sterile manner for up to five uses. Delfi Adaptive Tourniquet Cuffs are not designed to be resterilized. Dispose of properly after use.
Published
2026-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCYTourniquet, Pneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCYTourniquet, PneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M995995000183PackageHIBCC10In Commercial Distribution
M995995000181PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tourniquet cuff, single-useA band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+16047420600info@delfimedical.com

Regulatory Flags#

DUNS number
251078945
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M99597580024L1BFR Throwing Cuff, Reusable 9-7580-021L2026-01-14
M99592200250BFR3PTS BFR Tourniquet Instrument & Throwing Cuff Set 9-2200-250BFR2026-01-14
M99597580018L1BFR Throwing Cuff, Reusable 9-7580-018L2026-01-14
M99597580018R1BFR Throwing Cuff, Reusable 9-7580-018R2026-01-14
M99597580021R1BFR Throwing Cuff, Reusable 9-7580-021R2026-01-14
M995979800181Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7980-0182026-01-08
M995979800211Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7980-0212026-01-08
M995979900181Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7990-0182026-01-08
M995979900211Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7990-0212026-01-08
M995996000421Adaptive Cylindrical Cuff, Limited Reuse 9-9600-0422026-01-08
M995979700181Matching Limb Protection Sleeves for Adaptive Cuffs9-7970-0182026-01-08
M995979700241Matching Limb Protection Sleeves for Adaptive Cuffs9-7970-0242026-01-08
M995979700301Matching Limb Protection Sleeves for Adaptive Cuffs9-7970-0302026-01-08
M995979700341Matching Limb Protection Sleeves for Adaptive Cuffs9-7970-0342026-01-08
M995979700421Matching Limb Protection Sleeves for Adaptive Cuffs9-7970-0422026-01-08
M995979800183Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7980-0182026-01-08
M995979800213Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7980-0212026-01-08
M995979900183Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7990-0182026-01-08
M995979900213Matching Limb Protection Sleeves for PTS BFR Throwing Cuffs 9-7990-0212026-01-08
M995995000241Adaptive Cylindrical Cuff, Limited Reuse 9-9500-0242026-01-08

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Primary DI, Brand, Company table
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